Electromagnetic Fields (Emf) - Philips SmartSleep Manuel D'utilisation

Electromagnetic fields (EMF)

This headband complies with all applicable standards and regulations regarding
exposure to electromagnetic fields.
Specifications
Dimensions: 2.36" L x 5.12" W x 2.95" H (60 mm L x 130 mm W x 75 mm H)
Weight: Approximately 3.88 oz (110 g)
The expected useful life of the headband and battery is 2 years. The expected useful life
of the SmartSleep sensors is up to 3 uses.
Classifications and Standards Compliance
Classifications
Type of Protection Against
Electric Shock
Degree of Protection Against
Electric Shock
Degree of protection against
harmful ingress of water
Mode of Operation
• Not suitable for use in the presence of a flammable anesthetic mixture in
combination with oxygen or air, in the presence of nitrous oxide, or in an
oxygen-enriched environment.
Standards Compliance
Conforms to:
ETL Classi ed
• AAMI STD ES60601-1
• IEC STDS 60601-1-6, 60601-1-11, & 62304
Certified to:
• CSA STD C22.2 # 60601-1
5010469
The SmartSleep device is designed to conform to the following standards:
• IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for
Basic Safety and Essential Performance
• IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements
for Basic Safety and Essential Performance – Collateral Standard:
Electromagnetic Disturbances – Requirements and Tests
• IEC 60601-1-11 Medical Electrical Equipment – Part 1-11: General Requirements
for Basic Safety and Essential Performance – Collateral Standard: Requirements
for Medical Electrical Equipment and Medical Electrical Systems Used in the
Home Healthcare Environment
Class II Equipment/Internally powered
Type BF Applied part
Device: IP22, Drip Proof
Charger: IP20
First characteristic numeral - 2 - Protection against
ingress of solid foreign objects ≥ 12.5 mm diameter.
Explanation: Protected against access to hazardous
parts with a finger and protected against solid foreign
objects of 12.5 mm diameter and greater.
Second characteristic numeral - 2- Protection against
ingress of water with harmful effects dripping (15° tilted).
Explanation: Protected against vertically falling water
drops when enclosure tilted up to 15°.
Continuous operation
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